Z-1443-06

SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed...

Name: Z-1443-06 SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed...
Creator: Radiometer America Inc
Published: 2006-07-18
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-07-18 / Terminated

FDA source

Radiometer America Inc began a recall of SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each... on 2006-07-18. The reason FDA records is "Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1443-06
Status: Terminated
Initiated: 2006-07-18
Posted: 2006-08-29
Terminated: 2011-09-14
Recalling firm: Radiometer America, Inc
Product: SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
FDA root cause: Other
Action: The firm sent a recall letter to their customers on 7/18/2006. The letter identifies the problem, as well as the Part Numbers and Lot Numbers for the defective safePICO syringes subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected part numbers and lot numbers; 2) Identify and discard any of the affected product found on-hand; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
Quantity in commerce: 448 boxes x 100 per box [44,800 pouches]
Distribution: Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
Product codes and lots: The recalled product is identified with the following Part Numbers/Order No.; Lot Numbers; and Expiration Dates: Part #956-610, Lot #RD-28, and Expiration Date: 2008-01; Part #956-612, Lot #RJ-05, and Expiration Date: 2008-02; Part #956-614, Lot #RL-30, Expiration Date: 2008-03, Part #956-616, Lot #RQ-02, Expiration Date: 2008-04; and Part #956-623, Lot Code: RL22, and Expiration Date:2008-03

Product code JKA

K043143Class IISafepicoRadiometer Medical Aps / cleared 2005-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)